1.1 这种做法并不意味着将非大麻素成分或最终产品归类为可安全吸入。吸入清洁空气以外的任何东西都会对人类健康造成固有的风险。 1.2 本规范应概述从出发点（POD）计算拟用于蒸发大麻素产品的非大麻素成分的可接受每日吸入限值的步骤。 附注1: 要使用这种做法，用户必须事先确定所研究的非大麻素成分的POD以及本标准中规定的六个不确定因素和校正因素。 1.3 本实践应概述从POD或定义的TTC确定可用于拟定制剂中的非大麻素成分的最大允许浓度限值的步骤。1.4 本实践应概述将现有制剂中非大麻素成分的浓度与POD计算的每日可接受吸入限值或所研究非大麻素成分的规定TTC进行比较的步骤。 1.5 本实践应提供示例场景，以帮助实践的使用和理解如何执行计算。 1.6 本惯例不应定义根据生成的数据计算每日可接受吸入限值的方法 体外 . 1.7 本规范不应定义从致死剂量（例如，LC50或LD50）计算可接受每日吸入限值的方法。 1.8 本规范不应定义测定所研究非大麻素成分的POD或TTC的方法。1.8.1 使用者必须完成基于毒理学风险的评估，以确定所研究的非大麻素成分的POD或TTC。建议在进行风险评估时咨询有经验的毒理学家。 1.9 本标准并不旨在解决与其使用相关的所有安全性问题（如果有）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践并确定法规限制的适用性。 1.10 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。======意义和用途====== 4.1 意义: 4.1.1 该实践提供了一种将各种数据来源的非大麻素成分消耗限值外推至人类吸入消耗限值的方法。 4.1.2 该实践提供了一个易于理解的公式，用于计算正在研究的非大麻素成分的可接受每日吸入限值，并分解了执行计算所需的变量及其目的。 4.1.3 当这种做法应用于产品制造时，它可以提高消费者对大麻素产品和用于蒸发的非大麻素成分的信心。 4.1.4 这种做法可以帮助制造商降低与其产品相关的潜在健康风险，同时保持消费者获得多种大麻素-含有汽化产物。 4.1.5 这种做法与适当的风险评估相结合，将有助于指导监管机构和制造商优先考虑用于蒸发的含有大麻素的消费品中使用的非大麻素成分，以进行额外评估，通过将其努力和有限的资源集中在更有可能造成毒理学风险的物质上，从而降低消费者健康风险。 4.2 用途: 4.2.1 这种做法仅用于减少蒸发非大麻素成分对消费者健康的潜在负面风险。 4.2.2 本惯例不得用于确定非大麻素成分或大麻素产品可安全吸入。遵循这种做法并不意味着有权声称非大麻素成分或大麻素产品可以安全吸入。4.2.3 该实践旨在咨询有经验的毒理学家进行。 4.2.4 本惯例不打算用于根据致死剂量（例如，LC50或LD50）或根据生成的数据计算可接受的每日吸入限值 体外 . 4.2.5 根据目前可获得的用于蒸发的大麻素产品中使用的非大麻素成分的信息，这种做法可用于降低消费者健康风险。 4.2.6 该实践可用于计算正在研究的非大麻素成分的最保守的可接受每日吸入限值。 4.2.7 监管机构可以将这种做法与适当的风险评估结合使用，以得出单个成分的限量。利用这种做法，州监管机构将拥有一个科学工具来制定限制，为消费者提供保护并鼓励合法大麻素-遏制产品制造商和消费者留在受监管的市场。 4.2.8 用户有责任理解本文档中提出的概念并适当地使用它们。

1.1 This practice is not meant to classify the non-cannabinoid ingredient or final product as safe for inhalation. Inhaling anything other than clean air poses an inherent human health risk. 1.2 This practice shall outline the steps for calculating the acceptable daily inhalation limit from a point of departure (POD) for a non-cannabinoid ingredient intended for use in a cannabinoid product for vaporization. Note 1: To use this practice, the user must have previously determined the POD for the non-cannabinoid ingredient under investigation and six uncertainty factors stated in this standard and correction factors. 1.3 This practice shall outline the steps for identifying the maximum allowable concentration limit of a non-cannabinoid ingredient that could be used in a proposed formulation from a POD or a defined TTC. 1.4 This practice shall outline the steps for comparing the concentration of a non-cannabinoid ingredient in an existing formulation to the calculated acceptable daily inhalation limit from a POD or a defined TTC of the non-cannabinoid ingredient under investigation. 1.5 This practice shall provide example scenarios to aid in the usage of the practice and understanding of how to perform the calculation. 1.6 This practice shall not define the means for calculating the acceptable daily inhalation limit from data generated in vitro . 1.7 This practice shall not define the means for calculating the acceptable daily inhalation limit from a lethal dose (for example, LC50 or LD50). 1.8 This practice shall not define the means for determining a POD or TTC for the non-cannabinoid ingredient under investigation. 1.8.1 A user must complete a toxicological risk based assessment to determine a POD or TTC for a non-cannabinoid ingredient under investigation. It is recommended to consult an experienced toxicologist when conducting the risk assessment. 1.9 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.10 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 Significance: 4.1.1 This practice provides a means of extrapolating non-cannabinoid ingredient consumption limits from various sources of data to human inhalation consumption limits. 4.1.2 This practice provides an easy to understand equation for calculating the acceptable daily inhalation limit of a non-cannabinoid ingredient under investigation, and breaks down the variables necessary to perform the calculations and their purpose. 4.1.3 When this practice is applied to product manufacturing it can improve consumer confidence in cannabinoid products and non-cannabinoid ingredients intended for vaporization. 4.1.4 This practice can aid manufacturers in reducing the potential health risks associated with their products while maintaining consumer access to a wide variety of cannabinoid-containing vaporization products. 4.1.5 This practice, when combined with an appropriate risk assessment, will help to direct regulators and manufacturers in prioritizing non-cannabinoid ingredients used in consumer products containing cannabinoids intended for vaporization for additional evaluation to reduce consumer health risks by focusing their efforts and limited resources on substances more likely to pose a toxicological risk. 4.2 Use: 4.2.1 This practice is ONLY intended to be used to reduce potential negative consumer health risks from vaping non-cannabinoid ingredients. 4.2.2 This practice is NOT to be used to identify a non-cannabinoid ingredient or cannabinoid product as being safe for inhalation. Following this practice does not give the authority to claim a non-cannabinoid ingredient or cannabinoid product is safe for inhalation. 4.2.3 This practice is intended to be conducted in consultation with an experienced toxicologist. 4.2.4 This practice is not intended to be used for calculating the acceptable daily inhalation limit from a lethal dose (for example, LC50 or LD50), or from data generated in vitro . 4.2.5 This practice can be used to reduce consumer health risks based on information available today for non-cannabinoid ingredients used in cannabinoid products intended for vaporization. 4.2.6 This practice can be used to calculate the most conservative acceptable daily inhalation limit for a non-cannabinoid ingredient under investigation. 4.2.7 Regulators can use this practice in combination with an appropriate risk assessment for deriving individual ingredient limits. Using this practice, state regulators will have a scientific tool to create restrictions that can provide protection to consumers and encourage legal cannabinoid-containing product manufacturers and consumers to stay in the regulated market. 4.2.8 It is the responsibility of the user to understand the concepts presented in this document and to utilize them appropriately.